60 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ABX PENTRA DX 120: OPTION SPS EVOLUTION
FDA 510(k)
FDA Class 2
·Hematology
PYRAMESH® C Titanium Mesh
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855574·MESH 9050719 PYMSH IMPL 19MM END CAP
PYRAMESH® C Titanium Mesh
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484275·MESH 9050719 PYMSH IMPL 19MM END CAP
CPR Bag Reusable
FDA UDI
MERCURY ENTERPRISES, INC.·30641043507197·
NEOCARE 20 MICRON BLOOD FILTER
FDA 510(k)
FDA Class 2
·General Hospital
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
VPV SYSTEM
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF MEDOS·Product code JXG·January 6, 2014
CODMAN VIPV SYSTEM
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·November 5, 2010
CODMAN VPV SYSTEM
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·January 11, 2018
CODMAN VPV SYSTEM
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·October 1, 2016
BIPAP AUTO M-SERIES
FDA Adverse Event
Death
·RESPIRONICS, INC·Product code BZD·July 11, 2012
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 9, 2022
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 14, 2022
BIPAP AUTO BIFLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 14, 2022
CODMAN VPV SYSTEM
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·November 12, 2015
BIPAP AUTO SERIES ASSY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 31, 2022
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 14, 2022
BIPAP AUTO SERIES ASSY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code BZD·March 31, 2022
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
FDA Enforcement
Class II
·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 2017
CODMAN VPV SYSTEM
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC, MEDOS S.A.·Product code JXG·October 11, 2010